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Trial record 78 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

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ClinicalTrials.gov Identifier: NCT01815138
Recruitment Status : Completed
First Posted : March 20, 2013
Results First Posted : September 25, 2017
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lawrence Engmann, UConn Health

Brief Summary:
This a prospective randomized double blind study involving patients at high risk of OHSS development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant hCG 1,500 IU 35 hours after GnRH agonist trigger.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: hCG Phase 4

Detailed Description:

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. GnRH agonist trigger has been shown to be effective in OHSS prevention. However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.

Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has been shown that optimal conception rates is not achieved for high risk patients with peak serum E2 < 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later will rescue some of the corpora lutea and help improve corpora lutea function and improve pregnancy rates.

The study will evaluate patients at high risk of OHSS development with peak serum E2 < 4,000 pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy rates or risk of OHSS. Markers of corpus luteum function such as serum 17 hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus luteum function.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Double-blind Randomized Trial Comparing Pregnancy Rates After Low Dose Human Chorionic Gonadotropin (hCG) at the Time of Gonadotropin Releasing Hormone (GnRH) Agonist Trigger or 35 Hours Later for the Prevention of OHSS
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: hCG given at time of GnRHa trigger

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

Drug: hCG
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger
Other Name: Pregnyl, Profasi

Active Comparator: hCG given 35 hours after GnRHa trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

Drug: hCG
Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Other Name: Pregnyl, Profasi




Primary Outcome Measures :
  1. Ongoing Pregnancy [ Time Frame: Through time of study completion, on average 1-2years ]
    Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .


Secondary Outcome Measures :
  1. Ovarian Hyperstimulation Syndrome [ Time Frame: Within 4 weeks of oocyte retrieval ]
    Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.


Other Outcome Measures:
  1. Markers of Corpus Luteum Function [ Time Frame: Within 60 days after trigger of oocyte maturation ]
    A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.

  2. Proportion of Patients With Abdominal Distension [ Time Frame: Within 2 weeks after trigger of oocyte maturation ]
    Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have > 14 follicles of over 11 mm in diameter and with peak serum E2 levels < 4,000 pg/mL on the day of trigger of oocyte maturation.

Exclusion Criteria:

  • Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum E2 levels >= 4,000 pg/mL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815138


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Lawrence Engmann, MD UConn Health

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lawrence Engmann, MD, UConn Health
ClinicalTrials.gov Identifier: NCT01815138     History of Changes
Other Study ID Numbers: 13-098-3
First Posted: March 20, 2013    Key Record Dates
Results First Posted: September 25, 2017
Last Update Posted: October 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lawrence Engmann, UConn Health:
OHSS, GnRH agonist trigger, low dose hCG, PCOS, IVF
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Triptorelin Pamoate
Deslorelin
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents